nebupent

Generic: pentamidine isethionate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nebupent
Generic Name pentamidine isethionate
Labeler fresenius kabi usa, llc
Dosage Form INHALANT
Routes
RESPIRATORY (INHALATION)
Active Ingredients

pentamidine isethionate 300 mg/6mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-877
Product ID 63323-877_d673c124-d95f-4751-a11a-a26de8740b3a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019887
Listing Expiration 2026-12-31
Marketing Start 2011-02-15

Pharmacologic Class

Classes
antiprotozoal [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323877
Hyphenated Format 63323-877

Supplemental Identifiers

RxCUI
861597 861599
UNII
V2P3K60DA2

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nebupent (source: ndc)
Generic Name pentamidine isethionate (source: ndc)
Application Number NDA019887 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 300 mg/6mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-877-15) / 6 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

63323-877-15 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-877-15) / 6 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

pentamidine isethionate (300 mg/6mL)

Linked Drug Pages (1)

NebuPent ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "d673c124-d95f-4751-a11a-a26de8740b3a", "openfda": {"unii": ["V2P3K60DA2"], "rxcui": ["861597", "861599"], "spl_set_id": ["e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (63323-877-15)  / 6 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63323-877-15", "marketing_start_date": "20110215"}], "brand_name": "NebuPent", "product_id": "63323-877_d673c124-d95f-4751-a11a-a26de8740b3a", "dosage_form": "INHALANT", "pharm_class": ["Antiprotozoal [EPC]"], "product_ndc": "63323-877", "generic_name": "PENTAMIDINE ISETHIONATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NebuPent", "active_ingredients": [{"name": "PENTAMIDINE ISETHIONATE", "strength": "300 mg/6mL"}], "application_number": "NDA019887", "marketing_category": "NDA", "marketing_start_date": "20110215", "listing_expiration_date": "20261231"}